03/24/2025
Photo by Jaakko Kemppainen on Unsplash
In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior. The 2024 DoH is the eighth revision since 1964, replacing the previous revision which was adopted in 2013 in Fortaleza, Brazil. The DoH is a global reference of ethical principles intended to guide clinical trials researching human participant’s derived data and materials. These ethical principles are the basis for the 13 core principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and are essential for all clinical research stakeholders to understand in order to protect the rights, safety, and welfare of all clinical trial participants.
Notable changes from the 2013 revision include:
Participant-centered inclusion and respect.
This change includes the definitive transition of referring to research volunteers as “subjects” to “participants”. This change has been long advocated for and is now seen in other major clinical trial guidelines such as the recently adopted ICH E6 (R3). Using the term “subjects’ first appeared in international guidelines in the 1947 Nuremberg Code. “Subjects” however, assumes passivity of the volunteers that contradicts today’s standards of informed consent which implies that volunteers are actively participating in the research. The switch to “participants” highlights the concept that volunteers should be viewed as partners of clinical trial researchers and pays them their due respect within the trial since it is their rights, safety, and wellbeing that are being put on the line.
Increased recognition and protection of vulnerable populations.
This is seen in the change from 2013 DoH’s “Vulnerable Groups and Individuals” to the 2024’s “Individual, Group, and Community Vulnerability.” 2024’s point 19, in particular, greatly expands upon its predecessor, elaborating that vulnerability factors can be fixed or contextual and dynamic. It also explains that the exclusion of vulnerable populations from medical research could lead to further disparities within the populations, thus, the harms of their exclusion must be considered when planning clinical research.
Expansion of Research Ethics Committee’s responsibilities.
Point 23 of the 2024 DoH retains the majority of that in the 2016 DoH but adds factors such as:
Committees must have adequate education, training, qualifications, and diversity.
Committees must be familiar with local circumstances and context which is facilitated by including at least one member of the general public on the roster.
Studies being conducted internationally must have a committee’s approval in both the sponsoring and the host country(ies).
The entire Declaration and supplemental information can be found on the WMA website. As previously mentioned, the Declaration is considered the foundation for other international guidelines such as ICH-GCP, therefore, changes here may be reflected in how ICH countries plan, conduct, and report their clinical trials. The next Clinical Pathways blog entry will be looking at the interview between the Office of Global Policy and Strategy (OGSP) and the US Food and Drug Administration (FDA) staff on the FDA’s role in the revision of the DoH and how it will impact the administration.
If you or your company could benefit from consulting or training in all things GCP related, have a look at Clinical Pathways’ online store and course catalog to see if any of our services are the right fit for you. From now until the release on Friday, March 28th, take advantage of our pre-release sale for the Good Clinical Practice: ICH E6(R3) Training Course which will cover all of the changes made to the ICH GCP requirements in the latest revision. For further details or to secure this offer for you and your team, contact us at info@clinicalpathwaysresearch.com. While you’re there, consider subscribing to our free blog and newsletter to keep up to date on clinical trial related activity such as this.
-The Clinical Pathways Team
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